Generic Substitution URIBEL instruction

Uribel - clinical Phamacology

Generic Substitution uribel instructionHYOSCIAMIN sulfate is a sulfate that relaxes smooth muscles and thus produces a spasmolytic effect. It is well absorbed from the gastrointestinal tract and rapidly spreads throughout the body tissues. Most of the body's urine is absorbed within 12 hours, 13% to 50% unchanged. Its biotransformation of the liver. Ligation of his proteins? moderate.


METENAMIN decomposes in acidic Uribel release formaldehyde, which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. urine without change at some point substances, if the sour urine reaches 70% - 90%. Within 24 hours it is almost completely (90%) from the body; at pH 5, (about 20% is formaldehyde. Binding proteins ? some formaldehyde is due to substances in urine and surrounding tissues. Methenamine is free to spread to the body tissue and fluid, but is not clinically significant as it is not hydrolyzed at pH greater than 6.8.


METHILE BLUE has weak antiseptic properties. It is well absorbed by the gastrointestinal tract and is rapidly reduced to blue leukomethylene, which stabilizes in some form of combination in urine. 75% of the body is unchanged.


FENIL SALICILAT releases salicylate, a mild painkiller for pain.


MONOBASIC sodium PHOSPHATE acidifiers, helps to maintain the necessary for the degradation of Methenamine acid pH in the urine.


Readings and use for Uribel

Uribel capsules indicated peristalsis dehydration to treat symptoms. Indicated for local aid, symptoms such as inflammation, hypermotility and pain that accompany infections of the lower urinary tract. Indicated for assistance to the urinary tract symptoms caused by diagnostic procedures.

Contraidications

Generic Substitution uribel instructionHypersensitivity to any of the ingredients is possible. The benefits of risk should be carefully considered when the following medical problems exist: heart disease (especially cardiac arrhythmia, heart failure, coronary heart disease and mitral stenosis);  fda.gov obstructive gastrointestinal disease; glaucoma; myasthenia, acute urinary retention may have been produced in chronic uropathy (such as a neck bladder obstacle due to prostatic hypertrophy).

Warnings

Do not exceed the recommended dosage. If a rapid pulse, dizziness or blurred vision occurs, stop using immediately.

Precautions

Dmitry Sazonov sensitivity cross and/or related problems

can also be intolerant of this drug to patients intolerant of Belladonna alkaloids or salicylates. Delay in emptying the stomach may complicate the management of a stomach ulcer.


Pregnancy/propagation (FDA pregnancy Category C)

Giosciamine and Methenamine through the placenta. Research on the effects of hyoscyamine and Metenamine on pregnancy and reproduction has not been done in animals or humans. Thus, is it not known whether the Uribel capsules will damage the fetus when a pregnant woman is pregnant or may affect her reproductive potential. Uribel ? capsules should only be given to a pregnant woman if clearly necessary.


Breastfeeding

problems in the human body have not been documented; however, Methenamine and traces of hyoscyamine in mother's milk. Accordingly, Uribel capsules should be given to the breastfeeding mother with caution and only if clearly necessary.

Prolonged use

there have been no studies to establish the safety of long-term use in the human body. Unknown long-term studies on animals have been carried out to assess carcinogenicity potential.

In children

infants and young children are particularly susceptible to the toxic effects of Belladonna alkaloids.




AUTOMATIC GENERIC SUBSTITUTION

Automatic generic substitution (AGS) is the term for a scheme proposed by the Department of Health (DH) in 2009. AGS would have allowed pharmacists to dispense a generic version of a medication (a version with the same active ingredient), even if the doctor had written the prescription for a specific brand.


The Department of Health says no to AGS

After a consultation that resulted in written responses from 423 organisations and individuals, the DH announced, on 14 October 2010, that it had stopped plans to introduce AGS by pharmacists. The DH decided that concerns over patient safety were sufficiently grounded in fact and that it was therefore not appropriate to implement AGS.1

 

Taking Action Works!

The DH decided not to proceed with AGS as it reviewed the responses to the consultation and agreed that AGS was too great a risk to patients.

The correct use of medicines is important for achieving this goal, and the role of pharmacists is fully acknowledged in helping to achieve this. However, it is important that the relevant MHRA legislation is worded accurately to ensure that generic substitution or even therapeutic substitution by pharmacists is not inadvertently embedded in medicines legislation.

Thank you to those that acted last time - we are delighted that the DH listened to us and acted on our concerns.

Hexomedine

Parasinus

Cancer

Losing the right medication for the right patient

Norgine position paper

Norgine discussion. There is no Substitute

Outcome of DoH consultation on generic substitution

14th October 2010

Contacts

Julie Hornby Winfield
Norgine
[email protected]
+44 (0)1895 826642

Jennifer Garratt
Burson-Marsteller
[email protected]
+44 (0) 207 300 6240

References

  • The proposals to implement 'generic substitution' in primary care, further to the Pharmaceutical Price Regulation Scheme (PPRS) 2009. Response to the consultation.
  • MHRA Consolidation and review of UK medicines legislation. 25 October 2011. http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON132054 [Last accessed December 2011]

This website is sponsored by Norgine Pharmaceuticals Ltd


MEGS/2739/DEC11

Norgine Automatic Generic Substitution